Hyperuricemia on Hypertension and Metabolic Syndrome

Hepatic Enzymes Clinical Trial

Official title:

Effect of Hyperuricemia Treatment on Hypertension and Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157936
• Other study ID #: HYPERURICEMIA 2010
• Secondary ID: ALOPURINOL
• Status: Completed
• Phase: Phase 2
• First received: July 7, 2010
• Last updated: July 23, 2014
• Start date: July 2010
• Est. completion date: August 2011

Study information

• Verified date: July 2014
• Source: Instituto Nacional de Cardiologia Ignacio Chavez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health SecretariatMexico: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the influence of hyperuricemia treatment compared with placebo on participants with high risk of hypertension and metabolic syndrome.

Description:

Elevated consumption of high fructose corn syrup has lead to an increase of 30% of fructose intake since the last 20 years. Important data supporting this fact can be reflected on incidence and prevalence of Metabolic syndrome and hyperuricemia.

A peculiar effect of fructose intake demonstrated in animal models is the development of elevated uric acid levels; also some studies have found a clear association between hyperuricemia as an important risk factor for hypertension, diabetes mellitus, chronic kidney disease and metabolic syndrome.

Taking into account the existing evidence, our clinical research team presents this protocol as a way to evaluate the effect of uric acid treatment and its relation with Fructose consumption, metabolic syndrome parameters, hyperuricemia and risk of hypertension.

Confirming evidence with clinical basis may be the initial strategy to create primary prevention programs to control this health problems affecting Mexican Population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

• adults with blood pressure from 120/80 mmHg and less than 140/90 mmHg

• no pharmacological treatment for blood pressure control

Exclusion Criteria:

• hypertension (more than 140/90mmHg)

• Diabetes Mellitus type 1 or 2

• Chronic kidney disease (MDRD less than 60)

• Hepatic Disease

• Malignancy

• Pregnancy

• patient receiving any medication

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatic Enzymes
• Hypertension
• Hyperuricemia
• Metabolic Syndrome Parameters
• Metabolic Syndrome X
• Syndrome
• Systolic and Diastolic Blood Pressure Levels
• Uric Acid Levels

Intervention

Drug:
• Allopurinol
daily dosage

Other:
• placebo
daily dosage

Locations

Country	Name	City	State
Mexico	Insituto Nacional de Cardiología Ignacio Chávez	Mexico

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of hyperuricemia treatment on systemic blood pressure	participants will be randomized to a 4 week placebo versus alopurinol treatment followed by a wash out period. After crossover them, they will receive the complementary pharmacological intervention for another 4 weeks.	14 weeks	Yes
Secondary	Effect of hyperuricemia treatment on metabolic syndrome parameters	baseline and final laboratory samples during pre and post crossover periods will include metabolic syndrome measurements (triglycerides, cholesterol, glucose and abdominal perimeter).	14 weeks	Yes